Quality Assurance Specialist II

LifeScience Logistics•Memphis, TN

10h•Hybrid

About The Position

The Quality Assurance Specialist II will support regulatory inspections and customer audits, plan and present Quality System information, and maintain Quality Systems policies and procedures to ensure regulatory compliance. This role involves working with change controls, participating in internal and external audits, and releasing quarantined product. The specialist will review and approve product-specific paperwork, deviations, and CAPAs, assist the Operations team in root cause analysis and corrective actions, and contribute to quality improvement suggestions. The position also requires participation in cross-functional initiatives within a 3PL environment, strong leadership, logistics knowledge, and professional communication with customers.

Requirements

Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferred
Minimum of 1-3 years’ experience in a quality, preferably a logistics role
Strong understanding of a 3PL business, audits and complaints procedures
Validation and DEA experience strongly preferred
Medical Device, Pharma, and Plasma experience preferred
Effective time management skills
Impeccable verbal and written communication skills
Ability to conduct appropriate research as needed
Strong presentation skills
Attention to detail and organization
Critical thinking
Interest in working in a fast-paced environment
Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL
Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
Certified auditor training per ASQ or ISO (preferred)
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA
Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
Verifiable aptitude of FDA, OSHA and DEA regulations
Intermediate public speaking and presentation skills
Excellent verbal and written communication skills
Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
Must be able to travel up to 10%.
Must have a valid driver’s license

Nice To Haves

Validation and DEA experience strongly preferred
Medical Device, Pharma, and Plasma experience preferred
Certified auditor training per ASQ or ISO (preferred)

Responsibilities

Experience in temperature monitoring of controlled environments
Provide support during regulatory inspections and customer audits.
Plan and present Quality System information to internal and external groups
Demonstrate expert knowledge of Quality Systems
Familiar with Change Controls
Work to maintain Quality Systems policies and procedures to ensure regulatory compliance
Be a part of the internal audit team and assist in external audits
Release “quarantined” product upon receipt of documentation from Client and use Hold and Release process
Review/approve product-specific paperwork particular to Client guidelines
Help guide Operations team in determining root cause of discrepancies and help develop corrective actions and verification activities
Review and approve Deviations and CAPAs
Make suggestions on Quality improvements
Participate in cross-functional initiatives for a 3PL environment
Strong leadership skills and logistics (3PL) knowledge
Able to professionally communicate with customers/clients
Assist in returns and damages process
Perform record reviews to ensure compliance with all applicable procedures and regulations
Other duties as assigned